Agency Information Collection Activities: Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and Declaration of Law Enforcement Officer for Victim of Trafficking in Persons, Form I-914 and Supplements A and B. Extension, Without Change, of a Currently Approved Collection, 4168-4169 [2014-01385]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
4168
Federal Register / Vol. 79, No. 16 / Friday, January 24, 2014 / Notices
• A higher proportion of patients in
the high-dose group achieved target
mean arterial pressure (MAP) compared
to the lowest dose of 0.3 microgram/
kilogram/minute (mg/kg/min). The timeto-target MAP was also significantly
shorter for the high-dose groups.
• With a starting dose of 0.3 mg/kg/
min, ∼25 percent of patients achieved
target MAP in 5 minutes. Maintaining
on a stable dose of 0.3 mg/kg/min for 10
minutes resulted in ∼50 percent of
patients reaching target MAP. Hence, a
starting dose of 0.3 mg/kg/min is
reasonable. It should also be noted that
it may be prudent to maintain the
infusion rate for an additional 5 to 10
minutes before titrating.
• The proportion of patients with
MAP reductions of >20 percent below
target increased in a dose-dependent
manner.
• The safety profile of SNP in both
the trials was largely consistent with the
expected events as a result of the
underlying disease and preoperative
setting. Only blood pressure reduction
events were clearly drug- and doserelated.
• Even though only four neonates
were studied in the trial, there is no
expectation that the PK/PD relationship
and the safety profile would be any
different in this age group.
• The FDA Adverse Event Reporting
System (FAERS) search (up to October
25, 2012) retrieved only 26 pediatric
cases with SNP use. Of these, four cases
of elevated carboxyhemoglobin
associated with SNP treatment were
reported. The Office of Surveillance and
Epidemiology review outlines several
reasons why these data cannot be used
to calculate incidence of adverse events
in the population.
• For this submission, one large site
(N = 36 enrolled in Protocol NICHD–
2003–09–LT–SNP2; Investigator: Dr.
David Rosen) was inspected. The Office
of Scientific Investigations recommends
the data be accepted.
• As a part of the WR, long-term
safety data and a 1-year followup period
for patients enrolled in the trial were
sought. Information from followup was
not available in the submission.
However, the value of such information
is limited and is not expected to have
an impact on the ability to overcome the
labeling gap. The complete report can be
found at docket number FDA–2012–N–
0284.
II. Recommendation
The submission provides a reasonable
algorithm for administration of sodium
nitroprusside to allow its use in
perioperative settings to achieve
controlled hypotension for pediatric
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16:22 Jan 23, 2014
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patients from birth to 18 years. FDA’s
requested labeling changes are available
on the FDA Web site at https://
www.fda.gov/Drugs/
DevelopmentApprovalProcess/
DevelopmentResources/ucm379088.htm
and in the docket (Ref. 1).
III. Reference
Room 749, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested person
between 9 a.m. and 4 p.m., Monday
through Friday, and is available
electronically at https://
www.regulations.gov.
1. FDA Requested Labeling Changes.
[FR Doc. 2014–01386 Filed 1–23–14; 8:45 am]
Dated: January 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
U.S. Citizenship and Immigration
Services
[FR Doc. 2014–01390 Filed 1–23–14; 8:45 am]
[OMB Control Number 1615–0099]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney and Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel PAR12–265: NIDDK
Ancillary Studies to Major Ongoing Clinical
Research: Epidemiology of Gut Microbiome
in Diabetes.
Date: February 28, 2014.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Najma Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
PO 00000
Frm 00019
Fmt 4703
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Dated: January 17, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Agency Information Collection
Activities: Application for T
Nonimmigrant Status; Application for
Immediate Family Member of T–1
Recipient; and Declaration of Law
Enforcement Officer for Victim of
Trafficking in Persons, Form I–914 and
Supplements A and B. Extension,
Without Change, of a Currently
Approved Collection
ACTION:
60-day notice.
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
the general public and other Federal
agencies to comment upon this
proposed extension of a currently
approved collection of information or
new collection of information]. In
accordance with the Paperwork
Reduction Act (PRA) of 1995, the
information collection notice is
published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e. the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until March
25, 2014.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0099 in the subject box, the
agency name and Docket ID USCIS
USCIS–2006–0059. To avoid duplicate
submissions, please use only one of the
following methods to submit comments:
SUMMARY:
E:\FR\FM\24JAN1.SGM
24JAN1
Federal Register / Vol. 79, No. 16 / Friday, January 24, 2014 / Notices
(1) Online. Submit comments via the
Federal eRulemaking Portal Web site at
www.regulations.gov under e-Docket ID
number USCIS- USCIS–2006–0059;
(2) Email. Submit comments to
USCISFRComment@uscis.dhs.gov;
(3) Mail. Submit written comments to
DHS, USCIS, Office of Policy and
Strategy, Chief, Regulatory Coordination
Division, 20 Massachusetts Avenue
NW., Washington, DC 20529–2140.
SUPPLEMENTARY INFORMATION:
Comments
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to consider
limiting the amount of personal
information that you provide in any
voluntary submission you make to DHS.
DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Note: The address listed in this notice
should only be used to submit comments
concerning this information collection.
Please do not submit requests for individual
case status inquiries to this address. If you
are seeking information about the status of
your individual case, please check ‘‘My Case
Status’’ online at: https://egov.uscis.gov/cris/
Dashboard.do, or call the USCIS National
Customer Service Center at 1–800–375–5283.
Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
VerDate Mar<15>2010
16:22 Jan 23, 2014
Jkt 232001
e.g., permitting electronic submission of
responses.
DEPARTMENT OF HOMELAND
SECURITY
Overview of This Information
Collection
U.S. Citizenship and Immigration
Services
(1) Type of Information Collection:
Extension, Without Change, of a
Currently Approved Collection.
(2) Title of the Form/Collection:
Application for T Nonimmigrant Status;
Application for Immediate Family
Member of T–1 Recipient; and
Declaration of Law Enforcement Officer
for Victim of Trafficking in Persons.
(3) Agency form number, if any, and
the applicable component of the DHS
sponsoring the collection: Form I–914
and Supplements A and B; USCIS.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. Form I–914 permits victims
of severe forms of trafficking and their
immediate family members to
demonstrate that they qualify for
temporary nonimmigrant status
pursuant to the Victims of Trafficking
and Violence Protection Act of 2000
(VTVPA), and to receive temporary
immigration benefits.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: Form I–914, 500 responses at
2 hours and 15 minutes (2.25 hours) per
response; Supplement A, 500 responses
at 1 hour per response; Supplement B,
200 responses at 30 minutes (.50 hours)
per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 1,725 annual burden hours.
If you need a copy of the information
collection instrument with instructions,
or additional information, please visit
the Federal eRulemaking Portal site at:
https://www.regulations.gov. We may
also be contacted at: USCIS, Office of
Policy and Strategy, Regulatory
Coordination Division, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2140,
Telephone number 202–272–8377.
4169
[OMB Control Number 1615–NEW]
Dated: January 17, 2014.
Laura Dawkins,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2014–01385 Filed 1–23–14; 8:45 am]
BILLING CODE 9111–97–P
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities: Record of Abandonment of
Lawful Permanent Resident Status,
Form I–407; Existing Collection In Use
Without an OMB Control Number
ACTION:
30-day notice.
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection notice
was previously published in the Federal
Register on September 20, 2013, at 78
FR 57869, allowing for a 60-day public
comment period. USCIS received
comments from one commenter in
connection with the 60-day notice.
DATES: The purpose of this notice is to
allow an additional 30 days for public
comments. Comments are encouraged
and will be accepted until February 24,
2014. This process is conducted in
accordance with 5 CFR 1320.10.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, must be
directed to the OMB USCIS Desk Officer
via email at oira_submission@
omb.eop.gov. The comments submitted
to the OMB USCIS Desk Officer may
also be submitted to DHS via the
Federal eRulemaking Portal Web site at
https://www.regulations.gov under eDocket ID number USCIS–2013–0005 or
via email at uscisfrcomment@
uscis.dhs.gov. All submissions received
must include the agency name and the
OMB Control Number [1615–NEW].
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to consider
limiting the amount of personal
information that you provide in any
voluntary submission you make to DHS.
For additional information please read
the Privacy Act notice that is available
via the link in the footer of https://
www.regulations.gov.
SUMMARY:
E:\FR\FM\24JAN1.SGM
24JAN1
Agencies
[Federal Register Volume 79, Number 16 (Friday, January 24, 2014)]
[Notices]
[Pages 4168-4169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01385]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
U.S. Citizenship and Immigration Services
[OMB Control Number 1615-0099]
Agency Information Collection Activities: Application for T
Nonimmigrant Status; Application for Immediate Family Member of T-1
Recipient; and Declaration of Law Enforcement Officer for Victim of
Trafficking in Persons, Form I-914 and Supplements A and B. Extension,
Without Change, of a Currently Approved Collection
ACTION: 60-day notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Homeland Security (DHS), U.S. Citizenship
and Immigration Services (USCIS) invites the general public and other
Federal agencies to comment upon this proposed extension of a currently
approved collection of information or new collection of information].
In accordance with the Paperwork Reduction Act (PRA) of 1995, the
information collection notice is published in the Federal Register to
obtain comments regarding the nature of the information collection, the
categories of respondents, the estimated burden (i.e. the time, effort,
and resources used by the respondents to respond), the estimated cost
to the respondent, and the actual information collection instruments.
DATES: Comments are encouraged and will be accepted for 60 days until
March 25, 2014.
ADDRESSES: All submissions received must include the OMB Control Number
1615-0099 in the subject box, the agency name and Docket ID USCIS
USCIS-2006-0059. To avoid duplicate submissions, please use only one of
the following methods to submit comments:
[[Page 4169]]
(1) Online. Submit comments via the Federal eRulemaking Portal Web
site at www.regulations.gov under e-Docket ID number USCIS- USCIS-2006-
0059;
(2) Email. Submit comments to USCISFRComment@uscis.dhs.gov;
(3) Mail. Submit written comments to DHS, USCIS, Office of Policy
and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts
Avenue NW., Washington, DC 20529-2140.
SUPPLEMENTARY INFORMATION:
Comments
Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at https://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to consider limiting the
amount of personal information that you provide in any voluntary
submission you make to DHS. DHS may withhold information provided in
comments from public viewing that it determines may impact the privacy
of an individual or is offensive. For additional information, please
read the Privacy Act notice that is available via the link in the
footer of https://www.regulations.gov.
Note:
The address listed in this notice should only be used to submit
comments concerning this information collection. Please do not
submit requests for individual case status inquiries to this
address. If you are seeking information about the status of your
individual case, please check ``My Case Status'' online at: https://egov.uscis.gov/cris/Dashboard.do, or call the USCIS National
Customer Service Center at 1-800-375-5283.
Written comments and suggestions from the public and affected
agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Overview of This Information Collection
(1) Type of Information Collection: Extension, Without Change, of a
Currently Approved Collection.
(2) Title of the Form/Collection: Application for T Nonimmigrant
Status; Application for Immediate Family Member of T-1 Recipient; and
Declaration of Law Enforcement Officer for Victim of Trafficking in
Persons.
(3) Agency form number, if any, and the applicable component of the
DHS sponsoring the collection: Form I-914 and Supplements A and B;
USCIS.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract: Primary: Individuals or households. Form I-
914 permits victims of severe forms of trafficking and their immediate
family members to demonstrate that they qualify for temporary
nonimmigrant status pursuant to the Victims of Trafficking and Violence
Protection Act of 2000 (VTVPA), and to receive temporary immigration
benefits.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond: Form I-914, 500
responses at 2 hours and 15 minutes (2.25 hours) per response;
Supplement A, 500 responses at 1 hour per response; Supplement B, 200
responses at 30 minutes (.50 hours) per response.
(6) An estimate of the total public burden (in hours) associated
with the collection: 1,725 annual burden hours.
If you need a copy of the information collection instrument with
instructions, or additional information, please visit the Federal
eRulemaking Portal site at: https://www.regulations.gov. We may also be
contacted at: USCIS, Office of Policy and Strategy, Regulatory
Coordination Division, 20 Massachusetts Avenue NW., Washington, DC
20529-2140, Telephone number 202-272-8377.
Dated: January 17, 2014.
Laura Dawkins,
Chief, Regulatory Coordination Division, Office of Policy and Strategy,
U.S. Citizenship and Immigration Services, Department of Homeland
Security.
[FR Doc. 2014-01385 Filed 1-23-14; 8:45 am]
BILLING CODE 9111-97-P